A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes

A Multicenter Post-Marketing Observational Study to Evaluate the Long-Term Safety of Dorzagliatin in Patients With Type 2 Diabetes Mellitus

The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.

Study Overview

• Status: Recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Drug: Dorzagliatin tablets

Detailed Description

This study adopts a multicenter, prospective, and observational cohort study design and does not involve randomization, control, and blinding. Patients with type 2 diabetes mellitus who were prescribed Dorzagliatin according to the package insert and physician's judgment in routine medical practice setting will be included, and the data of these patients during 52-week Dorzagliatin treatment will be collected to evaluate the safety of long-term medication.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yi Zhang, MD,PhD; Phone Number: +8618502130980; Email: yzhang@huamedicine.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Bo Zhang, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-

Patients must meet all of the following inclusion criteria to be eligible for this study:

1. Male or female ≥ 18 years of age at the time of signing the informed consent form;
2. Patients with type 2 diabetes mellitus diagnosed at screening;
3. Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision);
4. Willingness to participate in the study and sign written informed consent.

Exclusion Criteria:

-

Patients will not be eligible if they meet any of the following criteria:

1. Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes;
2. Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin;
3. Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dorzagliatin group; Dorzagliatin tablet (75 mg, BID) treatment for 52 weeks	Drug: Dorzagliatin tablets; During the study, patients should follow the dosing instructions from the investigator, which are made according to the package insert and the patients' conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidences of ADRs and SAEs	The incidences of adverse drug reactions (ADRs) and serious adverse events (SAEs) as well as ADRs of special interest during the 52-week observation period of Dorzagliatin treatment.	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose indicators	Changes from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and 2-hour postprandial plasma glucose (2h-PPG) after 52 weeks of treatment with Dorzagliatin	52 weeks
Response rate	The proportion of patients with HbA1c < 7% after 52 weeks of treatment	52 weeks

Collaborators and Investigators

• Sponsor: Hua Medicine Limited
• Collaborators: Shanghai Branch, KunTuo Medical Research and Development (Beijing) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 16, 2024

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Post-Marketing; long term Safety; Dorzagliatin
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HMM0601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No